Adult: As an adjunct to diet and exercise: Monotherapy (if metformin is considered inappropriate due to contraindications or intolerance) or in combination with other antidiabetic agents: Old formulation (3 mg, 7 mg, and 14 mg tab)
Initially, 3 mg once daily for 1 month, then increase to 7 mg once daily. If additional glycaemic control is necessary, may further increase to 14 mg once daily after at least 1 month on the 7 mg dose.
New formulation (1.5 mg, 4 mg, and 9 mg tab)
Initially, 1.5 mg once daily for 1 month, then increase to 4 mg once daily. If additional glycaemic control is necessary, may further increase to 9 mg once daily after at least 1 month on the 4 mg dose.
The old formulation and new formulation are not substitutable on a mg per mg basis. Do not use both formulations at the same time. Do not take more than 1 tab per day to achieve the effect of a higher dose. Refer to specific product guidelines for detailed information on how to switch between formulations.
Subcutaneous Type 2 diabetes mellitus
Adult: As an adjunct to diet and exercise to improve glycaemic control or to reduce the risk of major CV events: Monotherapy (if metformin is considered inappropriate due to contraindications or intolerance) or in combination with other antidiabetic agents: Ozempic Initially, 0.25 mg once weekly for 4 weeks, then increase to 0.5 mg once weekly for at least 4 weeks. If glycaemic control is inadequate after at least 8 weeks of starting the treatment, may further increase dose to 1 mg once weekly. If additional glycaemic control is needed after at least 4 weeks on the 1 mg dosage, may further increase the dose up to Max of 2 mg once weekly. Doses are injected at any time of the day, on the same day each week, with or without meals. If changing the day of weekly administration is necessary, allow at least 2 or 3 days (>48 or >72 hours) between 2 doses. Dosing recommendations may vary between countries (refer to specific product guidelines).
Subcutaneous Weight management
Adult: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance in patients with an initial BMI of ≥30 kg/m2 (obesity) or ≥27-<30 kg/m2 (overweight) in the presence of at least 1 weight-related comorbidity (e.g. hypertension, dyslipidaemia, dysglycaemia, obstructive sleep apnoea) and to reduce the risk of major adverse CV events in patients with established CV disease and either obesity or overweight: Wegovy To reduce the risk of gastrointestinal symptoms, doses are escalated over a 16-week period up to achieving a maintenance dose. Dose escalation schedule: Week 1-4: 0.25 mg once weekly; Week 5-8: 0.5 mg once weekly; Week 9-12: 1 mg once weekly; Week 13-16: 1.7 mg once weekly; Week 17 and thereafter (maintenance dose): 2.4 mg once weekly. Doses are injected at any time of the day, on the same day each week, with or without meals. If changing the day of weekly administration is necessary, allow at least 2 or 3 days (>48 or >72 hours) between 2 doses. Reassess patients if unable to lose at least 5% of their initial body weight after 6 months of treatment. Child: ≥12 years As an adjunct to a reduced-calorie diet and increased physical activity for weight management in patients with obesity (BMI at the ≥95th percentile standardised for age and sex) and body weight >60 kg: Wegovy Same as adult dose. Dosing and treatment recommendations may vary between countries (refer to specific product guidelines).
What are the brands available for Semaglutide in Malaysia?
Semaglutide Injection: May be taken with or without food. Semaglutide Tab: Should be taken on an empty stomach. Take at least 30 min before first food/beverage/oral medication.
Contraindications
Hypersensitivity. Multiple endocrine neoplasia syndrome type 2 (MEN 2); personal or family history of medullary thyroid carcinoma (MTC).
Special Precautions
Patient with diabetic retinopathy; history of angioedema or anaphylaxis with another glucagon-like peptide-1 (GLP-1) agonist; history of pancreatitis. Not recommended in patients with severe gastroparesis. Not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Patients undergoing surgeries or procedures requiring deep sedation or anaesthesia may have an increased risk of pulmonary aspiration due to residual gastric contents caused by delayed gastric emptying associated with GLP-1 agonists. Semaglutide is available in multiple brands and preparations that are approved for specific indications; these brands and preparations are not interchangeable and must be used according to their approved indication; refer to specific product and international guidelines prior to administration. Potential misuse of GLP-1 agonists for unauthorised indications such as aesthetic weight loss has been reported; ensure the proper use of this medication, the risks and benefits of using GLP-1 agonists for weight loss outside of the approved indications have not been studied. Renal and severe hepatic impairment. Children. Pregnancy; discontinue treatment at least 2 months before a planned pregnancy. Lactation.
Adverse Reactions
Significant: Delayed gastric emptying, which may lead to pulmonary aspiration (particularly in patients undergoing general anaesthesia or deep sedation); dehydration leading to renal function deterioration; hypoglycaemia; acute kidney injury and worsening of chronic renal failure; serious hypersensitivity reactions (e.g. anaphylaxis, angioedema); gallbladder disease, biliary tract disease (e.g. cholelithiasis, cholecystitis); diabetic retinopathy; risk of suicidal thoughts or actions; gastrointestinal effects (e.g. abdominal pain, constipation, diarrhoea, nausea, vomiting, decreased appetite, dysgeusia, dyspepsia, xerostomia). Gastrointestinal disorders: Gastritis, GERD, flatulence. General disorders and administration site conditions: Fatigue, inj site reactions. Investigations: Increased lipase or amylase. Nervous system disorders: Dizziness. Skin and subcutaneous tissue disorders: Hair loss. Potentially Fatal: Acute pancreatitis including haemorrhagic or necrotising pancreatitis.
Patient Counseling Information
This drug may impair the ability to concentrate and react as a result of hypoglycaemia; if affected, do not drive or operate machinery. This drug may cause gastrointestinal effects (e.g. vomiting, diarrhoea) that may result in dehydration; ensure adequate fluid intake during treatment. Women of childbearing potential must use proven birth control methods during therapy.
Monitoring Parameters
Monitor plasma glucose, HbA1c, triglycerides, heart rate, weight and renal function. Assess for signs and symptoms of pancreatitis, gallbladder disease, diabetic retinopathy.
Drug Interactions
Increased risk of severe hypoglycaemia with insulin secretagogue (e.g. sulfonylurea) or insulin. Increased serum concentration of levothyroxine and rosuvastatin. Decreased INR with acenocoumarol.
Action
Description: Overview: Semaglutide, an incretin hormone analogue, is glucagon-like peptide-1 (GLP-1) receptor agonist. It is available in multiple preparations that are approved for specific indications; these preparations are not interchangeable.
Oral semaglutide has 2 formulations, the old and the new formulation, with different recommended doses. The new formulation (with increased bioavailability) is bioequivalent to the old formulation as described in the table below:
Old Formulation (One Oval Tablet)
New Formulation (One Round Tablet)
3 mg (initial dose)
1.5 mg (initial dose)
7 mg (maintenance dose)
4 mg (maintenance dose)
14 mg (maintenance dose)
9 mg (maintenance dose)
Refer to the dosage section for the dosing recommendation of the oral formulations. Mechanism of Action: Semaglutide selectively binds to and activates the GLP-1 receptors to increase glucose-dependent insulin secretion, decrease inappropriate glucagon secretion, and slows gastric emptying. Additionally, it acts in the brain areas that regulate the appetite and caloric intake. Pharmacokinetics: Absorption: Bioavailability: Approx 0.4-1% (old formulation tab); approx 1-2% (new formulation tab); 89% (SC). Time to peak plasma concentration: 1 hour (oral); 1-3 days (SC). Distribution: Volume of distribution: Approx 8 L (oral); approx 12.5 L (SC). Plasma protein binding: >99% to albumin. Metabolism: Metabolised via proteolytic cleavage of the peptide backbone with sequential β-oxidation of fatty acid side chain. Excretion: Via urine (approx 3% as unchanged drug); faeces. Elimination half-life: Approx 1 week.
Chemical Structure
Semaglutide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 56843331, Semaglutide. https://pubchem.ncbi.nlm.nih.gov/compound/Semaglutide. Accessed Feb. 25, 2025.
Storage
Tab: Store below 30°C. Protect from light and moisture. Solution for inj in pre-filled pen: Store between 2-8°C. Do not freeze. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
A10BJ06 - semaglutide ; Belongs to the class of glucagon-like peptide-1 (GLP-1) analogues. Used in the treatment of diabetes.
References
Brayfield A, Cadart C (eds). Semaglutide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/02/2025.GLP-1 and Dual GIP/GLP-1 Receptor Agonists: Potential Risk of Pulmonary Aspiration During General Anaesthesia or Deep Sedation. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 04/02/2025.GLP-1 Receptor Agonists: Reminder of the Potential Side Effects and to Be Aware of the Potential for Misuse. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 04/02/2025.Joint Formulary Committee. Semaglutide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/02/2025.Ozempic 0.5 mg Solution for Injection in Pre-filled Pen (Novo Nordisk A/S). MHRA. https://products.mhra.gov.uk. Accessed 04/02/2025.Ozempic 1.34 mg/mL (0.25 mg, 0.5 mg and 1 mg/dose) Solution for Injection in Pre-filled Pen (Novo Nordisk Pharma [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/02/2025.Ozempic Injection, Solution (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/02/2025.Rybelsus 1.5 mg, 4 mg, 9 mg, 25 mg, 50 mg and Rybelsus 3 mg, 7 mg, 14 mg, 25 mg, 50 mg Tablets (Novo Nordisk A/S). European Medicines Agency [online]. Accessed 04/09/2025.Rybelsus 3 mg, 7 mg and 14 mg Tablet (Novo Nordisk Pharma [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 18/02/2025.Rybelsus Tablet (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/09/2025.Semaglutide. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 04/09/2025.Semaglutide. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/09/2025.Semaglutide. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/09/2025.Wegovy 0.25 mg/0.5mL (0.25 mg/dose), 0.5 mg/0.5 mL (0.5 mg/dose), 1 mg/0.5 mL (1 mg/dose), 1.7 mg/0.75 mL (1.7 mg/dose) and 2.4 mg/0.75 mL (2.4 mg/dose) Solution for Injection in Pre-filled Pen (Novo Nordisk Pharma [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 18/02/2025.Wegovy 1.7 mg Solution for Injection in Pre-filled Pen (Novo Nordisk A/S). MHRA. https://products.mhra.gov.uk. Accessed 04/02/2025.Wegovy Flextouch 0.25 mg/dose (0.68 mg/mL), 0.5 mg/dose (1.34 mg/mL), 1 mg/dose (1.34 mg/mL), 1.7 mg/dose (2.27 mg/mL) and 2.4 mg/dose (3.2 mg/mL) Solution for Injection in Pre-filled Pen (Novo Nordisk Pharma [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 18/02/2025.Wegovy Injection, Solution (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/02/2025.